Ohio Admin. Code 4729:1-3-06 - Dispensing of epinephrine autoinjectors by pharmacists
(A)
A pharmacist may dispense an epinephrine autoinjector
without a prescription to either of the following in accordance with a protocol
specified in paragraph (B) of this rule:
(1)
An individual who
there is reason to believe is experiencing or at risk of experiencing
anaphylaxis if the pharmacy affiliated with the pharmacist has a record of
previously dispensing epinephrine to the individual in accordance with a
prescription issued by a licensed health professional authorized to prescribe
drugs; or
(2)
An individual acting on behalf of a qualified entity,
as defined in section
3728.01 of the Revised
Code.
(B)
A physician-established protocol for the dispensing of
epinephrine autoinjectors by a pharmacist or pharmacy intern under the direct
supervision of a pharmacist shall include, but is not limited to, the
following:
(1)
Indications for use of epinephrine autoinjectors, including
criteria for identifying persons eligible to receive an autoinjector under the
protocol.
(2)
Precautions and contraindications related to the
dispensing of epinephrine autoinjectors.
(3)
Epinephrine
autoinjectors authorized to be dispensed, including all the following
information:
(a)
Name of product;
(b)
Dose;
(c)
Quantity to be dispensed; and
(d)
Directions for
use.
(4)
Any patient instructions in addition to the training
specified in this rule and rule
4729:2-3-06 of the
Administrative Code.
(C)
(1)
A pharmacist who dispenses an epinephrine autoinjector
pursuant to this rule shall instruct the individual to whom the epinephrine
autoinjector is dispensed, either verbally or in writing, to summon emergency
services as soon as practicable either before or after administering
epinephrine.
(2)
A pharmacist who dispenses an epinephrine autoinjector
to an individual identified in paragraph (A) of this rule shall provide
notification of the dispensing to the individual's primary care provider, if
known, or to the prescriber who issued the individual the initial prescription
for an epinephrine autoinjector. Notification shall be conducted using one of
the following methods that is capable of confirming delivery of the required
notification:
(a)
Electronic mail;
(b)
Interoperable
electronic medical records system;
(c)
Facsimile;
(d)
Electronic prescribing system;
(e)
Electronic
pharmacy record system;
(f)
Documented verbal communication;
(g)
Any other method
of notification that might reasonably be expected to allow for the confirmed
transmission of the required notification.
(D)
When a
pharmacist dispenses an epinephrine autoinjector pursuant to this rule, the
pharmacist, or pharmacy intern under the direct supervision of a pharmacist,
shall provide to the person receiving the device instruction on the proper
method of administering epinephrine with the device.
(E)
A terminal
distributor of dangerous drugs shall ensure that all pharmacists that dispense
epinephrine autoinjectors pursuant to this rule are trained on the use of
epinephrine and can meet the training requirements listed in paragraphs (C) and
(D) of this rule.
(F)
A pharmacist may document the dispensing of an
epinephrine autoinjector by the pharmacist or pharmacy intern under the direct
supervision of the pharmacist on a prescription form. The form may be assigned
a number for record-keeping purposes.
(G)
This rule does
not affect the authority of a pharmacist to:
(1)
Dispense a new
prescription or refill for epinephrine; or
(2)
Contact a
prescriber to obtain a new oral prescription for an epinephrine autoinjector in
accordance with the applicable provisions of division 4729:5 of the
Administrative Code.
(H)
All
physician-established protocols must be signed and dated by the physician prior
to implementation and maintained by the terminal distributor of dangerous
drugs. The protocols shall be renewed by a physician on a biennial basis.
(1)
A physician may
sign one protocol for multiple locations licensed as terminal distributors of
dangerous drugs.
(2)
Each location licensed as a terminal distributor of
dangerous drugs shall maintain a copy of the protocol on-site for inspection by
an agent, inspector or employee of the state board of pharmacy.
Notes
Promulgated Under: 119.03
Statutory Authority: 4729.26, 4729.47
Rule Amplifies: 4729.47
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.